JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

JenaValve Technology, Inc.68 enrolled

Overview

To collect information about treatment for severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction

Interventions

JenaValve Pericardial TAVR SystemDEVICE

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with severe degenerative native aortic stenosis (AS). * Patient at high risk for open surgical valve replacement * Patient symptomatic according to NYHA functional class II or higher Exclusion Criteria: * Congenital uni- or bicuspid aortic valve morphology * Previous prosthetic aortic valve (bioprosthesis or mechanical) implant * Endocarditis or other active infection * Need for urgent or emergent TAVR procedure for any reason * Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device

Locations (13)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Columbia University Medical Center

New York, New York, United States

Deutsches Herzzentrum Berlin

Berlin, Germany

Outcomes

Primary Outcomes

All-Cause Mortality

All-cause mortality rate at 30 Day

Time frame: 30 Day

Secondary Outcomes

Myocardial Infarction

Peri-procedural and spontaneous myocardial infarction

Time frame: 30 Day

All Stroke/TIA

Neurological Complications

Time frame: 30 Day

Major Bleeding

Life threatening or major bleeding

Time frame: 30 Day

Major Vascular Complication

Major vascular and bleeding complications

Time frame: 30 Day

Conduction Disturbance and Arrhythmias

Conduction system injury (defect), including AV block, which may require a permanent pacemaker

Time frame: 30 Day

Acute Kidney Injury (AKI)

Number of patients who were diagnosed with AKI Stage 2 or 3: AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output \<0.5 mL/kg/h for \>12 but \<24 h AKI Stage 3: Increase in serum creatinine to ≥300% (\>3 × increase compared with baseline) OR serum creatinine of ≥4.0 mg/dL (≥354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output \<0.3 ml/kg/h for ≥24 h OR anuria for ≥12 h

Time frame: 30 Day

Coronary Obstruction Requiring Intervention

Coronary obstruction post-implant requiring intervention

Data from ClinicalTrials.gov

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